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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVOYAGER OTW CORONARY DILATATION CATHETER
Generic NameSTENT, CORONARY
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS222
Date Received06/04/2007
Decision Date09/27/2007
Reclassified Date10/08/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITION OF A LUBRICIOUS COATING TO THE INNER LUMEN OF THE CATHETER.
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